The Office for Regulatory Affairs (ORA) supports senior management, staff, students, and trainees in their commitment to follow DDI policies and standards of conduct to ensure they act ethically and in compliance with all applicable Ethics Committees laws’ and regulations. The Office’s responsibilities include:
- Overseeing and coordinating
the efforts of the Ethical Review Committee (ERC) and Animal Care & Ethics
- Identifying regulatory
compliance obligations of research activities.
- Ensuring that the principal
investigators and their team members are trained for conducting research
according to the policies and procedures of DDI and Good clinical practice as
per the ICH guidelines.
- Monitoring and auditing of
ethical aspect of research activities.
- Establishing procedures to
prevent, investigate, and correct non-compliance in research activities.
- Investigating and resolving
Scope & Responsibilities
Research-related relationships are reviewed and assessed by the ERC and ACEC to determine whether an actual conflict of interest exists. If an actual conflict is found, the ORA will work to manage, minimize, or eliminate the research-related conflict of interest by creating and approving a conflict management plan that may include one or more of the following:
- Requirement of appropriate
disclosure language on the subject consent form.
- Requirement of changes to
the consent of subjects’ process (for example, PI/investigator may not individually consent subjects).
- Requirement of full
disclosure to entire research team.
- Requirement of data
management plan and/or second party objective analysis of results.
- Requirement of disclosure
of the conflict relationship in publications.
ORA overlook 8 main regulatory affairs. These are:
- Ethical Review Committee.
- Animal research.
- Research compliance (Biomedical research /Population heath research/Clinical research).
- Research Ethics policy and procedures.
- Research integrity (grievance, ethical violation, misconduct, conflict of interest).
- Clinical trial research administration.
- Research document management.
- Cellular based research.